Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial
CoctailRCT
Cocktail of Vitamin B, Vitamin D and Melatonine VS Ibuprofen in the Surgical Third Molar Extraction. Randomized Clinical Trial
1 other identifier
interventional
12
1 country
1
Brief Summary
Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 21, 2025
CompletedAugust 21, 2025
August 1, 2025
2 months
June 20, 2025
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Post operative pain
VAS pain scale
10 DAYS
Swelling
Face measurement for swelling
7 DAYS
Trismus
Opening limitation
7 DAYS
Secondary Outcomes (2)
Rescue analgesia
7 DAYS
Inflammatory profile
7 days
Study Arms (2)
Ibuprofen 400
ACTIVE COMPARATORThree ibuprofen 400 doses
Coctail mixed Drugs
EXPERIMENTALVitamin D, Vitamin B and Melatonine at night instead Ibuprofen
Interventions
Surgical third molar extraction with conventional medication
Eligibility Criteria
You may qualify if:
- Healthy volunteers, non ibuprofen allergic, presence of impacted lower third molar
You may not qualify if:
- Diseases that avoid surgical intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complutense University of Madrid
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 20, 2025
First Posted
August 21, 2025
Study Start
February 1, 2025
Primary Completion
April 1, 2025
Study Completion
May 1, 2025
Last Updated
August 21, 2025
Record last verified: 2025-08